Senior Scientist/Associate Director, Safety Science

The Senior Scientist will report to the Head of Safety Science and is responsible for safety governance activities, signal detection/management, and risk management activities for Corcept products (investigational and marketed).

Responsibilities:

• Passionate about working on cutting edge research and developing advanced analytics/informatics solutions in the field of safety analytics and surveillance.
• Perform and contribute to safety analyses through review of case series, tabulated data and/or AE trend information.
• Contribute to document authoring, describing the evaluated safety data.
• Collaborate with more senior scientists and safety physicians on signal detection and risk management activities.
• Participate in the review of medical/scientific literature to identify literature relevant for signal detection activities and aggregate reporting.
• Participate in the preparation of aggregate safety reports.
• Contribute to consistent presentation of safety and risk management topics across various regulatory documents.
• Contribute, participate, and support safety deliverables related to cross functional or benefit-risk assessment meetings, including creation and maintenance of product core safety information, risk management plans (RMPs), company core data sheets (CCDSs).
• Contribute to health authority or other safety related query responses.
• Support PV vendor oversight, continuous process improvement, and inspections and audits.
• Maintain up to date knowledge related to technical area of expertise including areas of disease, drugs, data interpretation and integration, and regulatory and business environment.

Preferred Skills, Qualifications and Technical Proficiencies:

• Ability to work in a dynamic environment to meet corporate and patient needs.
• Excellent working knowledge of Argus (or similar applications), MS Office applications, electronic data capture systems, and MedDRA and WHO Drug coding dictionaries.
• Excellent presentation, communication, and collaboration skills.
• Knowledge of ICH guidelines
• Demonstrated success in taking the initiative in a team setting. Comfortable with ambiguity yet self-motivated and timeline driven.

Preferred Education and Experience:

• Registered Nurse, Pharmacist, or other degree in a Life Science-related field.
• Minimum 2 years safety and PV experience in the capacity of a scientist. Other relevant experience may be considered.
• Experience in writing safety analysis, performing signal detection or safety surveillance, risk management and preparing responses to HA.
• Experience in the authoring and review of periodic and ad hoc safety reports (such as PSURs, DSURs, Clinical Overviews, Clinical Study Reports or summaries) is preferred.
• Experience with NDA or MAA filing is a plus.

The pay range that the Company reasonably expects to pay for this position is $190,000 - $215,000; the pay ultimately offered may vary based on legitimate considerations, including job-related knowledge, skills, experience, and education.  An annual cash bonus and equity grants may be provided as part of the overall compensation package, in addition to a full range of medical, financial, and/or other wellness benefits, dependent on the position offered. 

Applicants must be currently authorized to work in the United States on a full-time basis.

If you are based in California, we encourage you to read this important information for California residents linked here.